Injection port applier with downward force actuation

ABSTRACT

An injection port applier is configured to engage an injection port that has integral fasteners that are movable from a non-deployed position to a deployed position. The applier comprises a shaft, a port engagement portion, and a handle. The port engagement portion is includes a fastener deployment member that is operable to move the fasteners to the deployed position. The handle comprises a first handle portion and a second handle portion. The second handle portion is movable distally relative to the first handle portion in order to actuate the fastener deployment member, to thereby move the fasteners to the deployed position. An elongate actuating member couples the second handle portion with the fastener deployment member. One part of the elongate actuating member translates longitudinally in response to the second handle being moved distally; while another part of the elongate actuating member rotates in response to the first portion translating.

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/166,625, filed Jun. 24, 2005, entitled “Implantable MedicalDevice with Reversible Attachment Mechanism and Method,” issued as U.S.Pat. No. 8,007,474, which is a continuation in part of U.S. patentapplication Ser. No. 10/741,875, filed Dec. 19, 2003, entitled“Subcutaneous Self Attaching Injection Port with Integral MoveableRetention Members,” issued as U.S. Pat. No. 7,862,546, which claimspriority to U.S. Provisional Patent Application Ser. No. 60/478,763,filed Jun. 16, 2003, entitled “Fluid Injection Port for AdjustableGastric Band.” The disclosure of each of those three patent applicationsis incorporated by reference herein.

This application also incorporates by reference the following U.S.patent applications, both of which were filed on Dec. 19, 2003:application Ser. No. 10/741,127, entitled “Subcutaneous Injection Portfor Applied Fasteners,” published as U.S. Pub. No. 2005/0131352; nowabandoned; and application Ser. No. 10/741,868, entitled “SubcutaneousSelf Attaching Injection Port with Integral Fasteners,” issued as U.S.Pat. No. 7,374,557.

TECHNICAL FIELD

The present invention relates generally to medical implants and applierstherefor, and more particularly to an attachment mechanism for use witha variety of medical implants and appliers for attaching such medicalimplants to body tissue. The invention will be disclosed in connectionwith, but not limited to, surgically implantable injection ports and anapplier therefor.

BACKGROUND

Implantable medical devices are typically implanted in a patient toperform a therapeutic function for that patient. Non-limiting examplesof such devices include pace makers, vascular access ports, injectionports (such as used with gastric bands) and gastric pacing devices. Suchimplants need to be attached, typically subcutaneously, in anappropriate place in order to function properly. It is desirable thatthe procedure to implant such devices be quick, easy and efficient. Inmany instances it would be beneficial if the surgeon could remove orreposition the device quickly, easily and efficiently.

Injection ports are placed beneath the skin of a body for injectingfluids into the body, such as for infusing medication, blood draws, andmany other applications, including adjustable gastric bands. Since theearly 1980s, adjustable gastric bands have provided an effectivealternative to gastric bypass and other irreversible surgical weightloss treatments for the morbidly obese. The gastric band is wrappedaround an upper portion of the patient's stomach, forming a stoma thatrestricts food passing from an upper portion to a lower portion of thestomach. When the stoma is of the appropriate size, food held in theupper portion of the stomach provides a feeling of fullness thatdiscourages overeating. However, initial maladjustment or a change inthe stomach over time may lead to a stoma of an inappropriate size,warranting an adjustment of the gastric band. Otherwise, the patient maysuffer vomiting attacks and discomfort when the stoma is too small toreasonably pass food. At the other extreme, the stoma may be too largeand thus fail to slow food moving from the upper portion of the stomach,defeating the purpose altogether for the gastric band.

In addition to a latched position to set the outer diameter of thegastric band, adjustability of gastric bands is generally achieved withan inwardly directed inflatable balloon, similar to a blood pressurecuff, into which fluid, such as saline, is injected through a fluidinjection port to achieve a desired diameter. Since adjustable gastricbands may remain in the patient for long periods of time, the fluidinjection port is typically installed subcutaneously to avoid infection,for instance in front of the sternum. Adjusting the amount of fluid inthe adjustable gastric band is achieved by inserting a Huber needlethrough the skin into a silicon septum of the injection port. Once theneedle is removed, the septum seals against the hole by virtue ofcompressive load generated by the septum. A flexible conduitcommunicates between the injection port and the adjustable gastric band.

The present invention encompasses an attachment mechanism to secure anmedical implant device to body tissue quickly and easily. The attachmentmechanism may be reversible, allowing the implantable medical device tobe detached quickly and easily for repositioning or removal. Althoughstandard, commercially available instruments may be used to actuate theattachment mechanism, the present invention also encompasses an applierfor locating an implantable medical device in the desired location andquickly and easily actuating the attachment mechanism to secure theimplantable medical device.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention,and, together with the general description of the invention given above,and the detailed description of the embodiments given below, serve toexplain the principles of the present invention.

FIG. 1 is a perspective view of an injection port with an attachmentmechanism constructed in accordance with the present invention.

FIG. 2 is a top view of the injection port of FIG. 1.

FIG. 3 is a bottom view of the injection port of FIG. 1.

FIG. 4 is a cross sectional view of the injection port of FIG. 1 takenalong line 4-4 of FIG. 3.

FIG. 5 is an exploded perspective view of the injection port of FIG. 1.

FIG. 6 is perspective view of the bottom of the injection port of FIG.1, showing the attachment mechanism in the retracted position.

FIG. 7 is a perspective view of the bottom of the injection port of FIG.1, similar to FIG. 6, showing the attachment mechanism in theextended/fired position.

FIG. 8 is a side cutaway view in partial cross-section illustrating afastener of the attachment mechanism in the retracted position.

FIG. 9 is a side cutaway view in partial cross-section similar to FIG. 8illustrating a fastener of the attachment mechanism that is beingadvanced by the actuator ring toward the extended/fired position.

FIG. 10 is a side cutaway view in partial cross-section similar to FIG.8 illustrating a fastener of the attachment mechanism in theextended/fired position.

FIG. 11 is a side cutaway view in partial cross-section similar to FIG.8 illustrating a fastener of the attachment mechanism that is beingadvanced by the actuator ring toward the retracted position.

FIG. 12 is a top view of the injection port of FIG. 1, with the actuatorring omitted to illustrate the positions of the links when the fastenersare in the retracted position.

FIG. 13 is a top view of the injection port of FIG. 1, with the actuatorring omitted to illustrate the positions of the links when the fastenersare in the extended/fired position.

FIG. 14 is an enlarged, fragmentary top view of the visual positionindicator and actuator ring detent system of the attachment mechanism ofFIG. 1, in the retracted position.

FIG. 15 is an enlarged, fragmentary top view of the visual positionindicator and actuator ring detent system of the attachment mechanism ofFIG. 1 in the extended/fired position.

FIG. 16 is an enlarged, fragmentary, exploded perspective view of thefitting and locking connector of the injection port of FIG. 1.

FIG. 17 is an enlarged, fragmentary partial cross-section view of thelocking connector assembled to the fitting the septum retainer but notlocked in place.

FIG. 18 is an enlarged, fragmentary partial cross-section view similarto FIG. 17 showing the locking connector locked in place.

FIG. 19 is an enlarged perspective view of the safety cap.

FIG. 20 is a perspective view of an applier constructed to implant theinjection port of FIG. 1.

FIG. 21 is a exploded, perspective view of the applier of FIG. 20.

FIG. 22 is a side view of the applier of FIG. 20 with one of the twobody halves showing the internal components in the unapplied,non-actuated position.

FIG. 23 is a side view of the applier of FIG. 20 similar to FIG. 22,showing the internal components in the applied, actuated position.

FIG. 24 is an enlarged, fragmentary side view of the linear to rotarycam mechanism of the applier of FIG. 20.

FIG. 25 is an enlarged top perspective view of the locator of theapplier of FIG. 20.

FIG. 26 is an enlarged bottom perspective view of the locator and theport actuator of the applier of FIG. 20.

FIG. 27 is a partially cut away end view of the locator of the applierof FIG. 20.

FIG. 28 is an enlarged, cross sectional view of the injection port ofFIG. 1 retained by the locator of the applier of FIG. 20.

FIG. 29 is an enlarged, cross-sectional view of the injection port ofFIG. 1 disposed in the locator of the applier of FIG. 20 after theapplier has been actuated to rotate the applier actuator to the deployedposition.

FIG. 30 is a diagrammatic drawing showing an injection port connected toan adjustable gastric band wrapped around an upper part of a stomach.

FIG. 31 depicts a block diagram of components of an exemplary modifiedversion of the injection port of FIG. 1.

Reference will now be made in detail to the present preferred embodimentof the invention, an example of which is illustrated in the accompanyingdrawings.

DETAILED DESCRIPTION

In the following description, like reference characters designate likeor corresponding parts throughout the several views. Also, in thefollowing description, it is to be understood that terms such as front,back, inside, outside, and the like are words of convenience and are notto be construed as limiting terms. Terminology used in this patent isnot meant to be limiting insofar as devices described herein, orportions thereof, may be attached or utilized in other orientations.Referring in more detail to the drawings, an embodiment of the inventionwill now be described.

Referring to FIGS. 1-5, there is shown an implantable medical device,more specifically an injection port, generally indicated at 2, whichembodies an attachment mechanism constructed in accordance with thepresent invention. Although the attachment mechanism is illustrated inthe figures as being embodied with injection port 2, the attachmentmechanism may be used with any implantable medical device for which itis suited, including by way of example only pace makers, vascular accessports, injection ports (such as used with gastric bands) and gastricpacing devices.

Injection port 2 includes septum retainer 4, septum 6 and port body 8.Injection port 2, with the integrally constructed attachment mechanism,also includes one or more fasteners 10, actuator 12 and a plurality oflink members 14.

As seen in FIG. 4, septum 6, which may be made of any biocompatiblematerial such as silicone, is disposed partially within internal cavity16 of septum retainer 4, adjacent annular flat 18. Septum retainer 4,port body 8, and actuator 12 may be made of any suitable biocompatiblematerial having sufficient stiffness and strength, such aspolyetheretherketon (known as PEEK). Fasteners 10 and link members 14may be made of any suitable biocompatible material, such as stainlesssteel.

Port body 8 includes annular rim 20, which engages the upper surface ofseptum 6 about an annular portion. Port body 8 is retained to septumretainer 4 by a plurality of pins 22 which are disposed throughrespective holes 24 formed in recesses 24 a in port body 8 and whichextend inwardly into respective recesses 26 formed about the bottomperiphery of septum retainer 4. Pins 22 may be made of any suitablebiocompatible material, such as stainless steel.

The uncompressed height of septum 6 is approximately 5 mm around theouter diameter and the uncompressed diameter is approximately 18 mm. Theexposed diameter for access to reservoir 20 is approximately 14 mm. Thedistance between the lower surface of annular rim 20 and annular flat 18is approximately 4 mm, such that septum 6 is compressed approximately20% to be adequately self healing to maintain a fluid tight system underpressure and still allow a low profile.

Plate 28 is disposed in recess 16 a formed in the bottom of septumretainer 4, underlying septum 6 and fluid chamber or reservoir 30. Asseen in FIG. 4, plate 28 does not contact sidewall 16 b. In theembodiment depicted, plate 28 is metallic, such as stainless steel. Whena needle is inserted through septum 6 to introduce or withdraw fluidfrom fluid chamber 30, such as in order to adjust the size of anadjustable gastric band, metallic plate 28 will protect septum retainer4 from puncture and provide tactile feedback to the surgeon through theneedle indicating that the needle has bottomed in reservoir 30. Plate 28may be secured to septum retainer 4 in any suitable manner. In theembodiment depicted, plate 28 is held in place by retaining lip 4 aextending over the periphery of plate 28 as best seen in FIGS. 4, 28 and29. Initially, retaining lip 4 a extends upwardly as an annular lip,providing clearance for insertion of plate 28 into the recess at thebottom of septum retainer 4, and retaining lip 4 a is then rolled orotherwise deformed to overlie at least a portion of the periphery ofplate 28 thereby retaining plate 28. In the embodiment depicted thediameter of recess 16 a is smaller than the diameter of sidewall 16 b,providing room to form the annular lip and to deform it into retaininglip 4 a. Plate 28 could be insert molded, with retaining lip 4 a moldedas illustrated.

Septum retainer 4 includes passageway 32, in fluid communication withfluid chamber 30, which is defined by fitting 34 extending from theperiphery adjacent the bottom of retainer 4. Tube 36, which in theembodiment depicted, leads to an adjustable gastric band (not shown), isconnected to fitting 34, being compressingly urged against annular rib38 by connector 40, which is disposed about tube 36 and secured to portbody 8 as described below. Sleeve 42 is disposed about tube 36, securedto connector 40 by annular ribs 44. Sleeve 42 relieves strain on tube36, preventing tube 36 from kinking when loaded laterally.

Actuator 12 is secured to port body 8. Although in the embodimentdepicted actuator 12 is illustrated as an annular ring rotatablysupported by port body 8, actuator 12 may be any suitable configurationand supported in any suitable manner to permit actuator 12 to functionto move fasteners 10 between and including deployed and undeployedpositions. As seen in FIG. 5, port body 8 includes a plurality ofdownwardly and outwardly extending tabs 46. In the embodiment depicted,there are four equally spaced tabs 46. Actuator 12 includes an equalnumber of corresponding recesses 48, each having arcuate bottom 50. Toassemble actuator 12 to port body 8, recesses 48 are aligned with tabs46, and pushed down, temporarily deflecting tabs 46 inwardly until tabs46 reach recesses 48 and move outwardly to dispose lower edges 46 a inrecesses 48 such that actuator is retained thereby. The lengths of tabs46 and depth of recesses 48 allow some axial end play between actuator12 and port body 8, as will be described below.

Actuator 12 may rotate generally about the central axis of port body 8.In the embodiment depicted, actuator 12 may rotate through an angle ofabout 40 degrees, although any suitable angle may be used. In theembodiment depicted, when actuator 12 is rotated in the deployingdirection, causing fasteners 10 to move to the deployed position,rotation of actuator 12 beyond the fully deployed position is limited byend 48 c contacting tab 46.

A detent system is formed by a pair of spaced apart raised detent ribs48 a, 48 b extending inwardly from the wall of each recess 48, and acorresponding raised rib 46 b extending outwardly from tab 46. Thedetent system assists in preventing actuator 12 from rotation andfasteners 10 from moving out of fully retracted or fully extended firedstates under vibration or incidental loads, as described below.

Actuator 12 includes a plurality of spaced apart openings or slots 54,which may be engaged by any suitable instrument to transmit thenecessary torque to actuator 12 to extend fasteners 10 to the actuatedposition. Slots 54 are configured to be engaged by commerciallyavailable instruments, rectangular in the embodiment depicted, or by thededicated applier described below. Port body 8 includes a plurality ofrecesses 56 disposed about its lower periphery which are configured tocooperate with the dedicated applier as described below.

Referring also to FIGS. 6 and 7, septum retainer 4 includes a pluralityof locating tabs 58 extending outwardly from adjacent the bottomperiphery of septum retainer 4. Locating tab 58 a may be integral withfitting 34. Tabs 58 and 58 a are located in respective complementarilyshaped recesses 60 formed in the inner surface of port body 8, aligningseptum retainer 4 properly with port body 8.

FIG. 6 illustrates fasteners 10 in the retracted position. As can beseen, fasteners 10 are disposed in respective recesses or slots 60formed in port body 8. FIG. 7 illustrates fasteners 10 in the extended,or fired, position, extending from slots 60. Rotation of actuator 12moves fasteners 10 from the retracted position to the extended position.

FIGS. 8-11 are a series of figures illustrating the operation ofactuator 12 and one of the plurality of fasteners 10, it beingunderstood that the operation on one of fasteners 10 may be the same asfor all fasteners 10, which may, in one embodiment, be moved from adeployed position to an undeployed position simultaneously. FIG. 8illustrates fastener 10 in a fully retracted state, the undeployedposition, disposed completely within slot 62 such that sharp tip 64 isnot exposed. This prevents tip 64 from accidentally sticking the surgeonor penetrating any object. Actuator 12 is illustrated rotated counterclockwise as far as permitted by recesses 48 and tabs 46. In thisposition, ribs 46 b are disposed clockwise of ribs 48 b, as seen in FIG.14. First ends 14 a of link members 14 are rotatably carried by actuator12, spaced apart at positions corresponding to the positions offasteners 10. Second ends 14 b are disposed within openings 66 offasteners 10.

To actuate the attachment mechanism, integral actuator 12 is rotated ina deploying direction, which in one embodiment as depicted is clockwise(any suitable direction configured to actuate the attachment mechanismmay be used), and rib 46 b passes rib 48 b, which may produce an audiblesignal in addition to a tactile signal to the surgeon. Second end 14 bof link member 14 is free to move within slot 66 during actuation, asthe force that rotates fastener 10 into the extended position istransmitted to fastener 10 through the interaction between cam surface68 of fastener 10 and actuating cam surface 70 of actuator 12. Asactuator 12 rotates clockwise, actuating cam surface 70 engages andpushes against cam surface 68, rotating fastener 10 about pivot pin 22.The majority of the force from actuating cam surface 70 actstangentially on cam surface 68, off center relative to pivot pin 22,causing fastener 10 to rotate. During actuation, end 14 b of link member14 remains free to move within slot 66, applying no driving force torotate fastener 10.

In FIG. 9, fastener 10 is rotated about half way though its range ofrotation, about 90 degrees as a result of the clockwise rotation ofactuator 12. As actuator 12 is rotated clockwise, the force betweenactuator cam surface 70 and cam surface 68 causes actuator 12 to moveupward slightly as allowed by the tolerancing of the components. Asactuator 12 is rotated further clockwise from the position shown in FIG.9, actuator cam surface 70 continues to engage and push against camsurface 68, rotating fastener 10 further counterclockwise.

In FIG. 10, actuator 12 is rotated clockwise to its fullest extent, withrib 46 b having been urged past detent rib 48 a (see FIG. 15). In thisposition, fastener 10 has rotated to its fullest extent, almost 180degrees in the embodiment illustrated, with tip 64 disposed withinrecess 62. In this position, actuator cam surface 70 is over center, andactuator 12 is resistant to being back driven by an undeploying forceimparted to fastener 10 as cam surface 68 acts against actuator camsurface 70 in a direction that tends to push actuator 12 up instead ofrotating actuator 12. The distal end portion of fastener 10 isconfigured essentially as a beam, depicted as having a generallyrectangular cross section along its length, tapering to sharp tip 64.With fastener 10 extending approximately 180 degrees in the fullyextended state, the deployed position, forces which might act onfasteners 10 tend to act through the pivot axis defined by pivot pin 22,instead of rotating fasteners 10. It is noted that although pin 22 isillustrated as being a separate piece from fastener 10, the two may beintegral or even of unitary construction.

If it is desirable to retract fasteners 10, such as to remove orreposition the implanted device, actuator 12 may be rotated in anundeploying direction, counterclockwise in one embodiment depicted.Starting with the position of actuator 12 shown in FIG. 10, actuator 12may be rotated counterclockwise, with actuator cam surface 70 slidingagainst cam surface 68, without rotating fastener 10. In the embodimentdepicted, continued counterclockwise rotation of actuator 12 moves camsurface 70 out of contact with cam surface 68, with no substantialrotating force being exerted on fastener 10 until second end 14 b oflink member reaches a location in slot 66, such as at one end of slot66, at which link member 14 begins pulling against slot 66 causingfastener 10 to rotate and begin to retract.

As seen in FIG. 11, actuator 12 has been advanced counterclockwisecompared to the position shown in FIG. 10, and fastener 10 is rotatedapproximately halfway through its range. As can be seen by comparingFIG. 9 to FIG. 11, actuator 12 is in different positions with fastener10 in the same position, in dependence upon whether the attachmentmechanism is being actuated or deactuated (retracted). This results fromthe lost motion that results when link member 14 is pulling on slot 66in comparison to actuator cam surface 70 pushing directly on cam surface68. To retract fasteners 10 fully, actuator 12 is rotated until detentrib 46 b snaps past detent rib 48 b.

Referring to FIG. 8, when fasteners 10 reach the fully undeployedposition tip 64 may be disposed fully in slot or recess 62. Furtherundeploying rotation of actuator 12 is prevented by link member 14 whichis prevented from further movement by fastener 10.

Referring to FIGS. 2 and 3, actuator 12 includes openings 52 a formedtherethrough, which align with corresponding openings 52 b formed inport body 8 when actuator is in the undeployed position. Openings 52 aand 52 b may be used by the surgeon to suture injection port 2 if theintegral attachment mechanism is not used.

Referring to FIGS. 12 and 13, the attachment mechanism is shown withoutactuator 12. Link members 14 are shown in their actual positions whenfirst ends 14 a are supported by actuator 12, in the deployed and in theundeployed states.

Referring to FIGS. 14 and 15, there is illustrated a top view of thevisual position indicator and a portion of the actuator ring detentsystem of the attachment mechanism as embodied in injection port 2. InFIG. 14, the attachment mechanism is in the retracted, undeployed stateor position. In this position, detent rib 46 b is clockwise of detentrib 48 b, and thus in the undeployed detent position. In FIG. 15, theattachment mechanism is in the actuated or deployed position. In thisposition, detent rib 46 b is counterclockwise of detent rib 48 b, andthus in the deployed detent position.

FIGS. 14 and 15 illustrate a visual indicator of the state of theattachment mechanism. As seen in FIG. 14, indicia may be utilized, suchas an unlocked lock icon 72 and a locked lock icon 74 molded integralwith actuator ring 12. Any suitable graphic indicator may be used, andmay be printed on or otherwise applied in a suitable manner. Port body 8may include indicator 76 to provide a reference point for the movableindicia. Arrow 78 may be included to indicate the bidirectional motionof actuator 12.

FIGS. 16-18 illustrate the locking connection between connector 40 andport body 8. FIG. 16 is an exploded perspective view showing fitting 34partially surrounded by extension 78. FIG. 17 shows extension 78 incross-section, with connector 40 generally disposed about fitting 34 andtube 36 aligned in circumferential slot 78 c of extension 78. Connector40 includes a pair of tabs 40 a, 40 b, extending outwardly therefrom. Toassemble, connector 40 is guided along tube 36 and fitting 34, with tabs40 a and 40 b aligned with openings 78 a and 78 b of extension 78. Withtabs 40 a and 40 b aligned with circumferential slot 78 c, connector 40is rotated to lock it in place. During rotation, detent edge 78 dcreates interference opposing the rotation of tab 40 a, but isdimensioned to allow tab 40 a to be rotated past, to the locked positionseen in FIG. 18.

FIG. 19 illustrates safety cap 80 which may be removably secured to thebottom of injection port 2 to cover fasteners 10 to protect users fromaccidental exposure to sharp tips 64 while handling injection port 2.Safety cap 80 includes body 82 with annular rim 84 and raised center 86defining annular recess 88. Safety cap 80 may be oriented and retainedto injection port through any suitable configuration. As depicted, body82 includes a plurality of arcuate retention tabs 90 extending upwardlyfrom raised center 86. Arcuate retention tabs 90 are shapedcomplementarily to corresponding arcuate slots 92, best seen in FIGS. 3,6 and 7, and may have ribs as shown. Safety cap 80 is secured toinjection port 2 by inserting arcuate retention tabs 90 into arcuateslots 92, which are sized to retain tabs 90. Fasteners 10 are thusaligned with annular recess 88, which is sized to allow fasteners 10 tobe extended without contacting safety cap 80. As depicted, since arcuateretention tabs 90 and arcuate slots 92 are respectively the same sizeand equally spaced, safety cap 80 is not indexed to a particularposition, and may be secured to injection port 2 in four differentpositions. Safety cap 80 includes pull tab 94 with raised a plurality ofribs 96 to provide a better gripping surface. Although pull tab 94 maybe oriented in any suitable orientation, in the embodiment, the relativeposition between pull tab 94 and arcuate retention tabs 90 locates pulltab at 45 degrees to the direction of connector 40. Tabs 90 and slots 92may be of any suitable shape.

As mentioned previously, the attachment mechanism may be actuated byengaging slots 54 with commercially available instruments or by adedicated applier. FIG. 20 illustrates applier, generally indicated at100, which is configured to position, actuate, deactuate, remove orreposition injection port 2. It is noted that the practice of aspects ofthe present invention as applied to an applier is not limited to thespecific applier embodiment depicted herein.

As shown in FIG. 20, applier 100 includes body 102, locator 104,actuator 106 and safety switch 108. As will be described below,injection port 2 may be assembled to locator 104, with extension 78 andtab 96 disposed in alignment slots 110 and 112. Locator 104 is angledrelative to body 102, allowing for easier and better visualization ofinjection port 2 during implantation. In the embodiment depicted, theangle is 20 degrees and the shaft portion of body 102 is 10 cm.

Referring to FIG. 21, body 102 includes first and second halves 102 aand 102 b assembled to each other to contain the internal components.Except for locating pins 202, pivot pins 114 and ship laps, body halves102 a and 102 b are substantially similar to each other. Locating pins202, illustrated as extending from body half 102 a, fit into respectivecomplementarily shaped openings (not illustrated) on body half 102 b.The engagement of the plurality of locating pins 202 in the openings issufficient to hold body halves 102 a and 102 b together. Pins 202 mayalternatively extend from body half 102 b with the openings carried bybody half 102 a. Any suitable configuration may be used to assemble andsecure body halves 102 a and 102 b together.

Actuator 106 includes first and second halves 106 a and 106 b. Locatingpins 204, illustrated as extending from actuator half 106 a, fit intorespective complementarily shaped openings (not illustrated) on actuatorhalf 106 b. Pins 204 may alternatively extend from actuator half 106 bwith the openings carried by actuator half 106 a. Any suitableconfiguration may be used to assemble and secure actuator halves 106 aand 106 b together. Body half 102 b includes pivot pin 114 b whichrotatably supports actuator 106 at one end, extending through pivotholes 116 a and 116 b into opening 114 a. Body half 102 a includes pivotpin 118 b (see FIG. 22) which rotatably supports safety switch 108. Bodyhalves 102 a and 102 b, locator 104, actuator halves 106 a and 106 b,and safety switch 108 may be made of any biocompatible material such aspolycarbonate.

Referring to FIGS. 21-24, applier 100 includes cam 120, drive shaft 122with flexible shaft 124, drive shaft pin 126, cam return spring 128,safety biasing spring 130, and actuator 132. Actuator 132 is configuredto effect the deployment or undeployment of the attachment mechanism ofthe medical implant. Cam 120 includes shaft 134 and cam collar 136. Theupper end of shaft 134 has a “T” configuration terminating in crossmember 138. Cam collar 136 defines a hollow interior and a pair ofspaced apart, complementarily shaped cam tracks 140 a and 140 b formedon opposite sides of cam collar 136. Upper end 122 a of drive shaft 122is disposed partially within the hollow interior defined by cam collar136, captured therein by drive shaft pin 126. Drive shaft pin 126 issized such that each end is located within a respective cam track 140 a,140 b. The length of the hollow interior allows upper end 122 a toreciprocate therein, with cam tracks 140 a and 140 b imparting rotationto drive shaft 122 through drive shaft pin 126 during reciprocation. Cam120, drive shaft 122 and actuator 132 may be made of any suitablematerial having sufficient stiffness and strength. In the embodimentdepicted, cam 120 and actuator 132 are made of a liquid crystal polymersuch as Vectra™ LCP, and drive shaft 122 is made of a PPE+PS such asNoryl™. Drive shaft pin 126 and cam return spring 128 may be made of anysuitable material, such as stainless steel.

Cam 120 is retained between body portions 102 a and 102 b, and in oneembodiment, such as that depicted can reciprocate. Cam collar 136 hasspaced apart, generally flat outer surfaces 142 a and 142 b tracksthrough which 140 a and 140 b are formed. These surfaces 140 a and 140 bare disposed between guide walls 144 a and 144 b formed in body portions102 a and 102 b. Cam collar 136 also includes oppositely facing channels146 a and 146 b (see FIG. 23), which are guided for axial reciprocationby guides 148 a and 148 b (not illustrated) formed in body portions 102a and 102 b, respectively. The upper end of shaft 134 and cross member138 are disposed sandwiched between actuator halves 106 a and 106 b.Each actuator half 106 a, 106 b, includes a cam track 150 defined by apair of spaced apart walls 150 a and 150 b extending from the interiorsurfaces of actuator halves 106 a and 106 b. Cam track 150 is configuredto receive and guide cross member 138 as actuator 106 is rotated aboutpin 114, forcing cam 120 to advance linearly downwardly into body 102.

Drive shaft 122 includes annular collar 152 which is received in slots154 a and 154 b (not illustrated) formed in body halves 102 a and 102 b,respectively. Slots 154 a and 154 b rotatably support drive shaft 122.Drive shaft 122 and cam 120 are generally aligned and collinear witheach other, defining the axis of the shaft portion of body 102. As cam120 is advanced downwardly, drive shaft pin 126 follows cam tracks 140 aand 140 b, causing drive shaft 122 to rotate, thus converting linearmotion to rotary motion. Cam return spring 128 provides a nominal returnforce against cam collar 136.

Flexible shaft 124 is supported by a plurality of ribs 156, formed ineach body half 102 a, 102 b, which support the bend in flexible shaft124 that permits the rotary motion to be transferred to actuator 132which is disposed at an angle relative to the shaft of body 102.Flexible shaft 124 may be made of any suitable biocompatible material,such as stainless steel. In an embodiment depicted, flexible shaft 124has a stranded construction, with a center core having multiple layersof wire wrapped thereabout. Ends 124 a and 124 b of flexible shaft 124may be attached to end 122 b and actuator 132, respectively, in anysuitable manner which sufficiently limits rotational end play to preventor minimize lost rotational motion. In an embodiment depicted, end 124 awas overmolded into end 122 b, and end 124 b was press fit into actuator132. Alternatively, end 124 a could be press fit into end 122 b, and end124 b overmolded into actuator 132, both could be press fit, or bothcould be overmolded (with a corresponding change to the configuration oflocator 104 to allow assembly.

Referring to FIGS. 21-25, actuator 132 includes disc shaped member 158and shaft 160 extending upwardly therefrom. The upper end of shaft 160includes a pair of outwardly extending tabs 162 a and 162 b. Locator 104includes hub 164 defining bore 166 therethrough. Bore 166 is shaped toreceive and rotatably support shaft 160, and includes two outwardlyextending arcuate recesses 168 a and 168 b configured to provideassembly clearance for tabs 162 a and 162 b, allowing hub 164 to beinserted into bore 166. The lengths of shaft 160 and hub 164 are sizedsuch that tabs 162 a and 162 b are located above upper surface 164 a ofhub 164, allowing rotation of actuator 132 while retaining it axiallyrelative to hub 164. Stops 170 and 170 b extend upwardly from uppersurface 164 a, limiting the rotation of actuator 132. Bore 166 defines acentral axis of locator 104 about which actuator 132 is rotated. Thecentral axis of locator 104 is disposed at an angle to the axis of theshaft portion of body 102, as previously mentioned.

Hub 164 includes a pair of oppositely extending tabs 172 a and 172 bwhich retain port actuator 104 to body 102 and prevent rotation. Bodyhalves 102 a and 102 b include respective recesses 174 a (see FIG. 21)and 174 b (not illustrated) shaped complementarily to tabs 172 a and 172b.

Referring also to FIGS. 26 and 27, disc shaped member 158 of actuator132 is seen disposed within locator 104. Actuator 132 includes a pair ofspaced apart posts 176 a and 176 b, extending from adjacent periphery158 a of member 158. Posts 176 a and 176 b are shaped complementarilywith openings 54. In the embodiment depicted, the distal ends of posts176 a and 167 b are tapered to assist in guiding posts 176 a and 176 binto openings 54. Any suitable configuration may be utilized to createreleasable contact between actuator 132 and actuator 12 capable ofactuating actuator 12.

Disc shaped member 158 also includes a pair of spaced apart cams 178 aand 178 b which extend outwardly and upwardly from periphery 158 a ofmember 158. FIG. 27 illustrates cam 178 a at a cross-section taken nearthe bottom surface of member 158. Cams 178 a and 178 b include ramps 180a and 180 b which start at periphery 158 a and lead out to surfaces 182a and 182 b, respectively. Each surface 182 a, 182 b is arcuate, shownin the embodiment depicted as generally having a constant radius.

In the embodiment depicted, locator 104 includes a pair of spaced apartcantilever arms 184 a and 184 b, each having rib 186 a and 186 b,respectively. For clarity, FIG. 27 illustrates arm 184 a incross-section taken through rib 186 a, at the same level as for cam 178a. At their distal ends, arms 184 a and 184 b include respectiveinwardly extending flanges 188 a and 188 b. Flanges 188 a and 188 b areshaped complementarily to recesses 56 on port body 8, configured toengage ledges 56 a when injection port 2 is retained by locator 104.

In the embodiment depicted, in the non-actuated state, posts 176 a and176 b are generally aligned with arms 184 a and 184 b, respectively,although posts 176 a and 176 b may be at any position that correspondsto position of the actuating feature of actuator 12, which in theembodiment depicted is openings 54. As actuator 106 is depressed,actuator 132 rotates (counterclockwise in the embodiment depicted whenviewed from the bottom), advancing cams 178 a and 178 b such that ramps180 a and 180 b contact ribs 186 a and 186 b, respectively, deflectingarms 184 a and 184 b outwardly. When surfaces 182 a and 182 b engageribs 186 a and 186 b, arms 184 a and 184 b are deflected a distancesufficient to move flanges 188 a and 188 b to a position where they nolonger extend into recesses 56 or contact ledges 56 a, thus releasinginjection port 2 from locator 104.

FIG. 28 illustrates injection port 2 disposed in and retained by locator104, with extension housing 78 and tab 96 disposed in slots 110 and 112,respectively (see FIG. 20, not seen in FIG. 28). As depicted, posts 176a and 176 b extend into openings 54 of actuator 12, and flanges 188 aand 188 b extending into recesses 56 proximal ledges 56 a. Safety cap 80is connected to injection port 12 when injection port 12 is insertedinto locator 104, covering fasteners 10 (not seen in FIG. 28).

Referring also to FIGS. 20 and 22, to insert injection port 2 intolocator 104, actuator 106 is oriented in the undeployed position so thatactuator 132 is in the undeployed position. Actuator 12 is oriented inthe undeployed position, and inserted into locator 104, with extensionhousing 78 and tab 96 disposed in slots 110 and 112, respectively.

Actuator 106 may, as illustrated in FIG. 20, include a visual indicatorto indicate whether actuator 106 is fully in the undeployed state, suchas unlocked lock icon 190, and indicia to indicate whether actuator 106is in the deployed state, such as locked lock icon 192. Such visualindication may be include by any suitable manner, such as by moldingintegral with actuator 106, applying as a adhesive film or such, orprinting directly on actuator 106. With the indicator illustrated,unlocked lock icon 190 is visible adjacent the upper edge of body 102,although other configurations of indication may be utilized, such as awindow or such formed in body 102 to reveal the indicia.

To use, locator 104 and a portion of 102, if necessary, is insertedthrough an incision by the surgeon and located in the desired positionadjacent the body tissue to which the medical implant (which in theembodiment depicted is an injection port 2) is to be attached. The anglebetween locator 104 and body 102 allows the surgeon to visualize thesite directly. With injection port 2 in position, the one or morefasteners 10 are moved from the undeployed position to the deployedposition in an annular path to engage the tissue. Fasteners 10 allowinjection port 2 to be secured to the tissue with a retention strengthequal to or greater than when secured with sutures. Safety switch 108 isrotated about pivot pin 118, withdrawing lockout tab 194 from loweropening 196, allowing actuator 106 to be rotated about pivot pin 114.This action causes cam track 150 to move cross member 138 downward,causing cam collar 136 to rotate drive shaft 122, thereby rotatingactuator 132 relative to locator 104.

Rotation of actuator 132 actuates actuator 12 by rotating it. Theengagement between extension 78 and tab 96 and slots 110 and 112,respectively, prevent port body 8 from rotating, allowing relativemotion between actuator 12 and port body 8.

Once actuator 106 reaches the deployed position, lockout tab 194 isurged into upper opening 198, retaining actuator 106 in the deployedposition. In the embodiment depicted, spring 130 biases lockout tab 194sufficiently to produce sound as lockout tab 194 snaps into upperopening 198, providing an audible signal that actuator 106, andtherefore actuator 12 and fasteners 10 are deployed fully. Asillustrated in FIG. 29, with actuator 106 in the deployed position,actuator 12 has been rotated and fasteners 10 are in the deployedposition having penetrated the body tissue, such as the rectus sheath.Cams 178 a and 178 b have been rotated to a position where surfaces 182a and 182 b are adjacent ribs 186 a and 186 b, with arms 184 a and 184 bdeflected outwardly such that flanges 188 a and 188 b are not disposedin recesses 56 and not engaging ledges 56 a. With injection port 2secured to the body tissue, and released from locator 104, the surgeonmay withdraw locator 104, leaving injection port 2 in place. If a visualindicator of the state of the attachment mechanism is included with theimplant, the surgeon can tell whether the attachment mechanism is fullydeployed.

The attachment mechanism embodied in injection port 2 is configured tobe reversible so that the medical implant, injection port 2, may bemoved, such as to reposition it or remove it from the patient. To do so,with actuator 106 in the deployed position, locator 104 is placed overinjection port 2, locating extension 78 and tab 96 in slots 110 and 112so that posts 176 a and 176 b are engaged with recesses 54. Safetyswitch 108 is rotated to withdraw lockout tab 194 from upper opening198, while the surgeon pulls up on extension 200 of actuator 106.Although cam return spring 128 urges cam collar 136 upwardly, extension200 allows an additional return force to be applied. As cross member 138is pulled up by cam track 150, actuator 132 rotates actuator 12, movingfasteners 10 from the deployed position to the undeployed positionsimultaneously, while cams 178 a and 178 b disengage from ribs 186 a and186 b, allowing flanges 188 a and 188 b to engage recess 56 and ledge 56a so as to retain injection port 2 in locator 104. When actuator 106 hasbeen moved to the undeployed position, lockout tab 194 snaps into loweropening 196, generating an audible signal that actuator 106 isundeployed fully, and injection port 2 is detached from the body tissueand may be relocated or removed.

In FIG. 30, adjustable gastric band 210 is shown wrapped around an upperportion of stomach 212, kept in place by attaching the two ends togetherand extending portion 214 of the stomach 212 over adjustable gastricband 210 by suturing portion 214 to the stomach. One end of flexibleconduit 216 is in fluid communication with the internal cavity of theballoon (not shown), with the other end being in fluid communicationwith an internal cavity of injection port 218. At the time adjustablegastric band 210 is implanted around a portion of the stomach, remoteinjection port 218 is also implanted at a suitable location, usuallywithin the rectus sheaths, for transcutaneous access via a Huber needle.

FIG. 31 depicts a schematic diagram of an exemplary alternative port1100 that is operable to provide haptic feedback in response topalpation and/or other types of stimulus as will be described in greaterdetail below. Port 1100 of this example includes a feedback interfacering 1202, a processor 1204, an interface sensor 1206, a power source1208, a vibration generator 1210, a storage device 1212, a telemetrytransceiver coil 1214, and a pressure sensor 1216. Port 1100 of thisexample is otherwise configured identically to port 2 described above.

In the present example, haptic feedback interface ring 1202 ispositioned between actuator 12 and port body 8. Haptic feedbackinterface ring 1202 is operable to sense when actuator 12 is beingpushed downwardly toward port body 8. Furthermore, and as will bedescribed in greater detail below, port 1100 may provide a vibratoryresponse when interface ring 1202 senses that actuator 12 is beingpushed downwardly toward port body 8. This vibratory response may assista physician in locating port 1100 through external palpation after port1100 has been implanted in a patient. Interface ring 1202 may compriseor form a switch that is in communication with a processor 1204 (e.g.,via wire, etc.) as will be described in greater detail below. Actuationof interface ring 1202 by pushing downward on actuator 12 (e.g., by aphysician palpating a patient, etc.) may thus actuate the correspondingswitch, which may cause processor 1204 to trigger the vibratoryresponse.

In some versions, port 1100 comprises one or more resilient members (notshown) that are configured to bias actuator 12 to an upper position. Byway of example only, interface ring 1202 may itself be configured tobias actuator 12 to an upper position. For instance, interface ring 1202may be resilient and may have a “wavy” configuration. Other ways inwhich actuator 12 may be biased to an upper position (regardless ofwhether actuator 12 is also rotatable) will be apparent to those ofordinary skill in the art in view of the teachings herein. Similarly,other suitable variations, components, features, and configurations ofinterface ring 1202 will be apparent to those of ordinary skill in theart in view of the teachings herein. By way of example only, interfacering 1202 may be substituted with one or more switches positionedbetween actuator 12 and port body 8, without a ring-shaped member beingused to form a vibratory response activation interface between actuator12 and port body 8. Such discrete switches may be equidistantlypositioned about a circumference or be positioned in any other suitablelocations/arrangement. As another merely illustrative example, port 1100may be configured such that interface ring 1202 does not move up anddown relative to port body 8. In some such versions, one or more straingauges or other types of sensors may be used to determine whether adownward force is being exerted on actuator 12, with such sensors beingconfigured to trigger a vibratory response as described in greaterdetail below. Alternatively, interface ring 1202 may be omitted in someversions, including but not limited to those versions described ingreater detail below.

In addition to providing some degree of axial play of actuator 12, port1100 may provide some degree of axial play for plate 28. In other words,plate 28 may slightly move up or down along the same axis about whichactuator 12 rotates. Such axial play may be provided without sacrificinga hermetic seal between plate 28 and septum retainer 4 or between plate28 and port body 8. In some versions, haptic feedback interface sensor1206 is positioned beneath plate 28. Interface sensor 1206 is operableto sense when plate 28 is being pushed downwardly. Furthermore, and aswill be described in greater detail below, port 1100 may provide avibratory response when interface sensor 1206 senses that plate 28 isbeing pushed downwardly. This vibratory response may assist a physicianin determining that a needle has struck plate 28, which may furtherindicate that the needle has been successfully inserted through septum6. Interface sensor 1206 may comprise or form a switch that is incommunication with processor 1204 (e.g., via wire, etc.) as will bedescribed in greater detail below. Actuation of interface sensor 1206 bypushing downward on plate 28 (e.g., by a needle striking plate 28, etc.)may thus actuate the corresponding switch, which may cause processor1204 to trigger the vibratory response.

In some versions, port 1100 comprises one or more resilient members (notshown) that are configured to bias plate 28 to an upper position. By wayof example only, interface sensor 1206 may itself be configured to biasactuator 12 to an upper position. For instance, interface sensor 1206may comprise a resilient ring positioned between the outer perimeter ofthe underside of plate 28 and septum retainer 4, and such a ring mayhave a “wavy” configuration. Other ways in which plate 28 may be biasedto an upper position will be apparent to those of ordinary skill in theart in view of the teachings herein. Similarly, other suitablevariations, components, features, and configurations of interface sensor1206 will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

In some other versions, port 1100 may be configured such that plate 28does not move up and down relative to septum retainer 4 and/or port body8. It should be understood that, in some such versions, various types ofinterface sensors 1206 may still be used to determine whether a downwardforce is being exerted on plate 28, with such sensors being configuredto trigger a vibratory response as described in greater detail below.For instance, interface sensor 1206 may comprise a thin film capacitiveswitch or strain gauge on plate 28. As yet another merely illustrativeexample, interface sensor 1206 may simply detect the presence of aneedle in fluid chamber 30, without necessarily detecting contactbetween the needle and plate 28 as such. For instance, interface sensor1206 may comprise a proximity sensor, an ultra wideband radar device, ametal detector that essentially ignores the metal of plate 28 whiledetecting the metal of a needle in fluid chamber 30, etc. Furthermore,it should be understood that interface sensor 1206 need not necessarilybe located under plate 28 (e.g., interface sensor 1206 may be in fluidchamber 30, etc.). Still other suitable components and configurationsthat may be used for interface sensor 1206 will be apparent to those ofordinary skill in the art in view of the teachings herein.Alternatively, interface sensor 1206 may be omitted in some versions,including but not limited to those versions described in greater detailbelow.

Injection port 1100 may also include a chamber (not shown) located belowplate 28. The chamber may be enclosed and hermetically sealed, such thatit is fluidly isolated relative to fluid chamber 30. This extra chambermay enclose several electrical components that are configured to providevibratory responses as noted above. For instance, the extra chamber mayenclose processor 1204, interface sensor 1206, a power source 1208, avibration generator 1210, and a storage device 1212 (e.g., flash memory,memory chip, etc.). Of course, any or all of these components may belocated elsewhere if desired. While these components are only shown inblock form in the drawings, the various structural forms that thesecomponents may take will be apparent to those of ordinary skill in theart in view of the teachings herein. Interface ring 1202, interfacesensor 1206, power source 1208, vibration generator 1210, and storagedevice 1212 are all in communication with processor 1204 (e.g., viawires and/or traces in a circuit board, etc.). Processor 1204 maycomprise an off the shelf microprocessor, a customized processor 1204,or any other suitable type of device or component. Processor 1204 isconfigured to receive input from interface ring 1202 and interfacesensor 1206, and is configured to trigger vibratory responses throughvibration generator 1210 as will be described in greater detail below.Processor 1204 is also configured to interrogate storage device 1212,and may also be configured to cause data to be stored on storage device1212.

Power source 1208 of the present example comprises a conventionalbattery. It should be understood, however, that power source 1208 mayinstead be substituted with a transcutaneous energy transfer (TET) coil,such that components shown in FIG. 31 are powered remotely by a coilthat is external to the patient. For instance, in versions where port1100 includes a telemetry transceiver coil 1214 as described in greaterdetail below, such a transceiver coil 1214 may serve a dual role ofreceiving TET power and providing telemetric communication of data. Asanother merely illustrative example, where power source 1208 comprises abattery, such a battery may be recharged through TET power. Still othersuitable ways in which power may be provided to electrical/electroniccomponents of port 1100 will be apparent to those of ordinary skill inthe art in view of the teachings herein.

In some versions, interface ring 1202 and/or interface sensor 1206 areomitted. In some such versions, vibration generator 1210 is activated byan external coil. For instance, such an external coil may be configuredin accordance with the teachings of U.S. Pub. No. 2006/0211914, entitled“System and Method for Determining Implanted Device Positioning andObtaining Pressure Data,” published Sep. 21, 2006, the disclosure ofwhich is incorporated by reference herein. Other suitable forms thatsuch an external coil may take will be apparent to those of ordinaryskill in the art in view of the teachings herein. In some versions wherevibration generator 1210 is activated by an external coil, telemetrytransceiver coil 1214 may be communicatively and transcutaneouslycoupled with the external coil. In particular, transceiver coil 1214 andprocessor 1204 may respond to a field generated by the external coil byactivating vibration generator 1210. In addition, the external coil andtelemetry transceiver coil 1214 may together provide power to vibrationgenerator 1210 via TET. Thus, a battery or other implanted power source1208 need not be included within port 1100. It should be understood fromthe foregoing that a physician may locate port 1100 by sweeping over thepatient's abdomen and/or chest with the external coil until vibrationsare felt from vibration generator 1210. Such vibrations may reach amaximum intensity when the external coil is directly over port 1100. Thephysician may then insert the needle through the center of external coilto reach port 1100; or may first remove external coil then insert theneedle where the center of the external coil was when vibrations fromvibration generator 1210 were at their maximum intensity.

In some versions where an external coil is used to activate vibrationgenerator 1210, vibration generator 1210 comprises a conventional typeof vibration generator (e.g., such as those described in greater detailbelow, etc.). In some such versions, the external coil simply activatesvibration generator 1210, which is actually powered by power source 1208within port 1100. In other words, the field generated by the externalcoil simply acts as a switch to cause vibration generator 1210 togenerate vibrations. In some other versions where vibration generator1210 comprises a conventional type of vibration generator, the externalcoil provides power to vibration generator 1210 through TET as describedabove. Of course, vibration generators 1210 that are turned on by anexternal coil and/or are powered by an external coil need not beconventional, and may take any suitable form. Various forms thatvibration generator 1210 may take, as well as various ways in whichvibration generator 1210 may operate and be used, are disclosed in U.S.patent application Ser. No. 12/640,048, filed Dec. 17, 2009, entitled“Implantable Port with Vibratory Feedback,” the disclosure of which isincorporated by reference herein.

It should also be understood that vibration generator 1210 may be usedfor a variety of purposes. One merely exemplary use for vibrationgenerator 1210 may be to assist a physician in locating port 1100 afterport 1100 has been implanted in a patient. For instance, depending onthe location of port 1100 within the patient and the obesity of thepatient, some physicians may have difficulty in locating a conventionalimplanted port 1100. The physician may wish to locate port 1100 in orderto insert a needle into septum 6 to add fluid to or withdraw fluid fromthe gastric band system. In some settings where port 1100 includes aTET/telemetry coil, the physician may wish to locate port 1100 in orderto properly position an external coil or other type of antenna in orderto provide power to and/or receive data from components in the port1100. Accordingly, where port 1100 has been implanted in the patient,the physician may palpate the patient's abdomen and/or chest in order tolocate port 1100. When the physician palpates over the location of port1100, such palpation may press actuator 12 downward, which may activateinterface ring 1202, which may in turn activate vibration generator 1210to provide haptic feedback to the physician indicating that the port1100 is generally beneath the physician's hand. The physician may theninsert the needle in this area to pierce septum 6 in order to add fluidto or withdraw fluid from the gastric band system.

In some settings, actuator 12 may occasionally be pressed down by thepatient's own movements or positioning. It may be desirable to preventsuch incidental pressing of actuator 12 from triggering a vibratoryresponse by vibration generator 1210. To that end, processor 1204 may beconfigured to compare downward forces exerted on actuator 12 against apredetermined force threshold level, such that processor 1204 onlytriggers vibration by vibration generator 1210 when the downward forceon actuator 12 exceeds the predetermined threshold. The force thresholdmay be selected such that incidental pressing on actuator 12 by patientmovement/positioning falls below the threshold; while sufficientexternal palpation by a physician exceeds the threshold. Datarepresenting such a force threshold may be stored on storage device1212. In some other variations, processor 1204 may be configured suchthat it will not trigger vibration by vibration generator 1210 unlessthe presence of some external signal is detected. For instance, controllogic in processor 1204 may be configured to cause processor 1204 toignore activations of interface ring 1202 unless coil 1214 is receivingsome type of signal from a coil that is external to the patient. Such anexternal signal may thus simply “unlock” vibration generator 1210, suchthat external palpation by a physician may activate vibration generator1210 only when vibration generator 1210 is “unlocked” by the externalsignal. Alternatively, an external signal may directly cause vibrationgenerator 1210 to generate vibrations as noted above. Still othersuitable ways in which port 1100 may prevent a vibratory response toinadvertent pressing of actuator 12 will be apparent to those ofordinary skill in the art in view of the teachings herein. Of course,some versions of port 1100 may lack such prevention; and some otherversions of port 1100 may lack a feature permitting actuator 12 to bepressed in relative to other portions of port 1100.

Another merely exemplary use for vibration generator 1210 may be toassist a physician in confirming that the needle has successfullyreached fluid chamber 30 to adjust the amount/pressure of fluid in animplanted gastric band system. For instance, even when a physician hasdetermined the general location of port 1100 implanted in a patient, thephysician may have difficulty determining whether a needle inserted inthe patient has successfully reached fluid chamber 30. A physician maygenerally determine through tactile feedback felt through the needle andsyringe that the needle has struck some hard object, but the physicianmay not be able to determine whether the needle has struck plate 28 orsome other hard component of port 1100 (e.g., needle may have insteadstruck actuator 12, port housing 8, etc.). Accordingly, when thephysician has successfully inserted the needle into fluid chamber 30 andthe needle has struck plate 28, such striking of plate 28 by the needlemay activate interface sensor 1206, which may in turn activate vibrationgenerator 1210 to provide haptic feedback to the physician indicatingthat the needle has reached fluid chamber 30. The physician may then usethe syringe and needle to add fluid to or withdraw fluid from theimplanted gastric band system, to adjust the size of the stoma createdby gastric band 210.

In situations where the physician feels the inserted needle strikingsomething hard but does not receive the vibratory response fromvibration generator 1210, such a lack of vibratory response may indicateto the physician that the needle has missed septum 6 (e.g., needleinstead struck actuator 12, port housing 8, etc.) and that the needle istherefore not in fluid chamber 30. The physician may then partially orfully withdraw the needle and reposition it for another attempt topierce septum 6 and reach fluid chamber 30. This process may be repeateduntil the physician finally receives haptic feedback from vibrationgenerator 1210 to indicate that the needle has successfully reachedfluid chamber 30.

In some versions where port 1100 includes both interface ring 1202 andinterface sensor 1206, it may be desirable to vary the response fromvibration generator 1210 based on whether interface ring 1202 orinterface sensor 1206 has been activated. This may be desirable in somesettings to account for the possibility that a physician may strikeactuator 12 with an inserted needle instead of striking plate 28. Makingthe vibratory response when interface sensor 1206 is triggered differentfrom the vibratory response when interface ring 1202 is triggered maythus allow the physician to confirm that the inserted needle has struckplate 28 instead of actuator 12. The vibratory response from vibrationgenerator 1210 may differ in a variety of ways, including but notlimited to frequency, waveform, magnitude, duration, and/or pulsepattern, etc., based on whether interface ring 1202 or interface sensor1206 has been activated. Of course, some versions may provide the samevibratory response from vibration generator 1210 regardless of whetherinterface ring 1202 or interface sensor 1206 has been activated.Furthermore, some versions of port 1100 may have only interface ring1202 or only interface sensor 1206; while lacking the other.

In some alternative versions, port 1100 lacks interface sensor 1206. Insome such versions, vibration generator 1210 is operable to generateexternally palpable vibrations based on actuation of interface ring1202, based on the presence of an externally applied field, or based onsome other form of activation. Furthermore, such vibrations may besustained as a physician inserts a needle into a patient. Alternatively,such vibrations may be initiated upon the needle contacting an externalportion of port 1100. In some such versions, vibration generator 1210may cause the entire port 1100 to vibrate. It should be understood thatsuch vibrations may be acoustically coupled with the needle in differentways depending on the material of the port 1100 that is struck by theneedle. For instance, port body 8 (including annular rim 20) andactuator 12 may be formed of a substantially hard material (e.g.,plastic and/or metal, etc.); while septum 6 may be formed of arelatively soft material (e.g., silicone, etc.). Thus, when the needlestrikes a relatively hard portion of vibrating port 1100, the acousticcoupling may provide a “scratchy” vibratory sensation through the needleto the physician's hand. Such a tactile sensation may inform thephysician that the needle is in contact with port 1100 but not insertedthrough septum 6. The physician may then reposition the needle until thephysician feels a “softer” vibratory sensation through the needle thatwould be associated with the needle being inserted through septum 6 ofvibrating port 1100. As one merely illustrative variation of thisexample, port 1100 may be configured such that vibration is maximized atannular rim 20 surrounding septum 6, which may provide greater guidanceto the physician who is attempting to locate septum 6 based onhaptic/tactile feedback. For instance, portions of port 1100 that areexternal to annular rim 20 may be vibrationally isolated or dampenedrelative to annular rim 20, such that those external portions either donot vibrate while annular rim 20 vibrate or such that the vibrations ofthose external portions have a lower amplitude than the vibrations ofannular rim 20.

Yet another merely exemplary use for vibration generator 1210 may be toprovide an alert when some condition has been detected. By way ofexample only, some versions of port 1100 may include a pressure sensor1216 that is configured to sense the pressure of fluid in a gastric bandsystem. Various suitable ways in which a pressure sensor 1216 may beincorporated into a gastric band system are disclosed in U.S. Pub. No.2006/0211914, entitled “System and Method for Determining ImplantedDevice Positioning and Obtaining Pressure Data,” published Sep. 21,2006, the disclosure of which is incorporated by reference herein.Alternatively, any other suitable type of pressure sensor 1216 may beincorporated into the gastric band system in any suitable fashion. WhileFIG. 31 depicts pressure sensor 1216 as a component of port 1100, itshould be understood that pressure sensor 1216 may be located in anyother suitable position or component.

Processor 1204 may be configured to monitor readings from pressuresensor 1216 and compare those readings to one or more baselines storedon storage device 1212. Processor 1204 may further be configured totrigger a vibratory response by vibration generator 1210 when a pressuredata reading from pressure sensor 1216 deviates from a baseline orrange. For instance, processor 1204 may trigger a vibratory response byvibration generator 1210 when the pressure of fluid in the gastric bandsystem falls below a threshold (e.g., approximately 10 mmHg, etc.),which may indicate that there is a leak in the system, that more fluidneeds to be added to the system, or some other condition. Similarly,processor 1204 may trigger a vibratory response by vibration generator1210 when the pressure of fluid in the gastric band system exceeds athreshold (e.g., approximately 50 mmHg, etc.), which may indicate thatfluid needs to be withdrawn from the system, or some other condition.Such pressure-based feedback may be felt by the patient, and may promptthe patient to contact their physician for an adjustment of gastric band210. The physician may then investigate further and provide anyappropriate medical response (e.g., adding fluid to or withdrawing fluidfrom the gastric band system, etc.). By way of example only,pressure-based feedback that is provided to the patient may comprise afew short bursts of vibration provided every half hour, a slightvibration two or three times a day, etc. In some versions, only onethreshold value is provided (e.g., either an upper threshold to triggervibratory alert when exceeded or a lower threshold to trigger vibratoryalert when fallen below).

As noted above, port 1100 may be secured within patient by swivelingfasteners 10, with fasteners 10 being swiveled to the extended/deployedposition upon rotation of actuator 12. As also noted above, ribs 48 a,48 b and ribs 46 b of port 1100 provide a detent system that providesresistance to inadvertent rotation of actuator 12, thereby providingresistance to inadvertent retraction of swiveling fasteners 10. Itshould also be understood that this detent system may also provideresistance to inadvertent rotation of actuator 12 that might otherwisebe caused by vibration of vibration generator 1210. Of course, a varietyof other structures, components, features, or configurations may be usedto prevent or resist inadvertent rotation of actuator 12 that mightotherwise be caused by vibration of vibration generator 1210.Furthermore, port 1100 might lack swiveling fasteners 10 and might besecured within the patient in some other fashion. By way of exampleonly, port 1100 may be secured within the patient using sutures, tacks,staples, biosurgical adhesive, and/or using any other suitablecomponents, devices, or techniques, including combinations thereof.

In some settings, it may be desirable to deactivate vibration generator1210 until port 1100 has been implanted in the patient. In other words,it may be desirable in some settings to prevent vibration generator 1210from vibrating before and during the process of installing port 1100 inthe patient. Otherwise, pressing of actuator 12 during the process ofinstalling port 1100 in the patient might activate interface ring 1202and thereby cause vibration generator 1210 to vibrate. There are avariety of ways in which vibration generator 1210 may be disabled beforeinstallation of port 1100 is complete. For instance, one or more bossesor other types of mechanical lockout feature may prevent actuator 12from being moved downwardly toward port body 8 until after actuator 12has been rotated to deploy fasteners 10 to the extended position. Asanother merely illustrative example, actuator 12 and/or interface ring1202 may be configured such that downward movement of actuator 12 doesnot engage interface ring 1202 until after actuator 12 has been rotatedto deploy fasteners 10 to the extended position. As yet another merelyillustrative example, port 1100 may include a switch or other featurethat enables interface ring 1202, with such a switch or other featurebeing engaged by actuator 12 after actuator 12 has been rotated todeploy fasteners 10 to the extended position. Still other suitable waysin which rotation of actuator 12 to the fastener 10 deploying positionmay be required in order to enable vibration of vibration generator 1210will be apparent to those of ordinary skill in the art in view of theteachings herein.

As yet another variation, port 1100 may be configured such thatvibration generator 1210 is unable to vibrate (even if actuator 12 ispressed downward) until after an initial enabling signal has beentransmitted from an external coil to coil 1214 of port 1100. In otherwords, processor 1204 may include a logic that requires coil 1214 tofirst receive an unlocking signal or enablement signal before processor1204 will command vibration generator 1210 to vibrate in response toactuator 12 being pressed downward. A physician may provide such anunlocking signal or enablement signal after port 1100 has been installedin the patient. Vibration generator 1210 may then be enabled to vibratein response to downward pressing on actuator 12, even if such anexternal unlocking signal or enablement signal is no longer beingtransmitted to coil 1214. In a relatively simpler version, port 1100 maysimply include a switch on its exterior that the physician maymanipulate in order to make vibration generator 1210 responsive todownward pressing on actuator 12. Still various other suitable ways inwhich responsiveness of vibration generator 1210 may be selectivelyenabled and/or disabled will be apparent to those of ordinary skill inthe art in view of the teachings herein.

While interface ring 1202 and interface sensor 1206 both “share” acommon vibration generator 1210 and processor 1204 in the presentexample, it should be understood that interface ring 1202 and interfacesensor 1206 may alternatively each have their own dedicated vibrationgenerator 1210 and/or processor 1204. Accordingly, the inventorscontemplate that the components shown in FIG. 31 may alternatively beprovided in various other suitable numbers and/or arrangements.Furthermore, each of the components shown in FIG. 31 is merely optional.

It should be understood from the foregoing that vibration generators1210 may be incorporated into virtually any type of implanted device.The above described examples of gastric band systems are mereillustrations. The inventors' contemplation is not limited to componentsof gastric band systems. By way of example only, a vibration generator1210 may be incorporated into an implanted drug infusion port,chemotherapy port, or any other type of implantable port that is used todeliver medication, to help a physician locate the implanted portthrough palpation of the patient. Still other types of implanted devicesthat may incorporate a vibration generator 1210 will be apparent tothose of ordinary skill in the art in view of the teachings herein.Likewise, any other teachings herein (e.g., relating to fasteners 10,etc.) may be incorporated into other devices and systems, and arecertainly not limited to injection ports or gastric band systems.

Other suitable components, features, and operabilities that may beincorporated into port 2, 1100 are disclosed in U.S. patent applicationSer. No. 12/640,048, filed Dec. 17, 2009, entitled “Implantable Portwith Vibratory Feedback,” the disclosure of which is incorporated byreference herein. Still other suitable components, features, andoperabilities that may be incorporated into port 2, 1100 will beapparent to those of ordinary skill in the art in view of the teachingsherein.

In summary, numerous benefits have been described which result fromemploying the concepts of the invention. The foregoing description ofone or more embodiments of the invention has been presented for purposesof illustration and description. It is not intended to be exhaustive orto limit the invention to the precise form disclosed. Modifications orvariations are possible in light of the above teachings. The one or moreembodiments were chosen and described in order to illustrate theprinciples of the invention and its practical application to therebyenable one of ordinary skill in the art to utilize the invention invarious embodiments and with various modifications as are suited to theparticular use contemplated. It is intended that the scope of theinvention be defined by the claims submitted herewith.

We claim:
 1. An injection port applier, wherein the injection portapplier is configured to engage an injection port having integralfasteners that are movable from a non-deployed position to a deployedposition, the injection port applier comprising: (a) a shaft having aproximal end and a distal end; (b) a port engagement portion at thedistal end of the shaft, wherein the port engagement portion isconfigured to engage an injection port, wherein the port engagementportion comprises a fastener deployment member operable to move thefasteners of the injection port from the non-deployed position to thedeployed position; and (c) a handle at the proximal end of the shaft,wherein the handle includes: (i) a first handle portion integral withthe shaft, and (ii) a second handle portion movable relative to thefirst handle portion, wherein the second handle portion is movabledistally, toward the first handle portion, to actuate the fastenerdeployment member to move the fasteners of the injection port from thenon-deployed position to the deployed position.
 2. The injection portapplier of claim 1, wherein at least part of the first handle portionextends transversely from the shaft.
 3. The injection port applier ofclaim 1, wherein at least part of the second handle portion extendstransversely relative to the shaft.
 4. The injection port applier ofclaim 1, further comprising an elongate actuating member coupled withthe second handle portion, wherein the elongate actuating member is incommunication with the fastener deployment member, wherein the elongateactuating member is movable along a longitudinal axis defined by theelongate actuating member.
 5. The injection port applier of claim 4,wherein the elongate actuating member extends through at least part ofthe shaft.
 6. The injection port applier of claim 4, further comprisinga cam pin and a cam ground, wherein the cam pin extends transverselyfrom the elongate actuating member, wherein the cam pin is configuredand positioned to engage the cam ground.
 7. The injection port applierof claim 6, wherein the cam ground defines a track, wherein the cam pinis disposed in the track.
 8. The injection port applier of claim 7,wherein the track is curved.
 9. The injection port applier of claim 6,wherein the cam ground comprises a cam collar, wherein the elongateactuating member extends through the cam collar, such that the camcollar is disposed about the elongate actuating member.
 10. Theinjection port applier of claim 6, wherein the cam ground and the campin are configured to cooperate to rotate at least part of the elongateactuating member about the longitudinal axis of the elongate actuatingmember as the elongate actuating member is moved along the longitudinalaxis of the elongate actuating member.
 11. The injection port applier ofclaim 10, wherein the fastener deployment member is rotatable from afirst position to a second position to move the fasteners of theinjection port from the non-deployed position to the deployed position,wherein at least part of the elongate actuating member is operable torotate the fastener deployment member in response to the cam pin and camground rotating at least part of the elongate actuating member.
 12. Theinjection port applier of claim 4, wherein the elongate actuating memberhas a bent flexible portion, wherein the flexible portion is configuredto rotate while bent in order to rotate the fastener deployment member.13. The injection port applier of claim 1, further comprising aresilient member, wherein the resilient member is configured to bias thesecond handle portion proximally, away from the first handle portion.14. The injection port applier of claim 1, wherein the first handleportion is pivotally coupled with the second handle portion.
 15. Aninjection port applier, wherein the injection port applier is configuredto engage an injection port having integral fasteners that are movablefrom a non-deployed position to a deployed position, the injection portapplier comprising: (a) an elongate body having a proximal end and adistal end; (b) an actuating shaft assembly extending through at least aportion of the elongate body; (c) a port engagement portion at thedistal end of the elongate body, wherein the port engagement portion isconfigured to engage an injection port, wherein the port engagementportion comprises a port actuator operable to move the fasteners of theinjection port from the non-deployed position to the deployed position,wherein the actuating shaft assembly is movable relative to the elongatebody in order to move the port actuator to thereby move the fasteners ofthe injection port from the non-deployed position to the deployedposition; and (d) a handle at the proximal end of the elongate body,wherein the handle comprises: (i) a first handle portion in a fixedrelationship with the elongate body, and (ii) a second handle portionmovable relative to the first handle portion, wherein the second handleportion is coupled with the actuating shaft assembly, wherein the secondhandle portion is movable distally, toward the first handle portion, tomove at least part of the actuating shaft assembly relative to theelongate body.
 16. The injection port applier of claim 15, wherein afirst portion of the shaft assembly is configured to translatelongitudinally relative to the elongate body, wherein a second portionof the shaft assembly is configured to rotate relative to the elongatebody.
 17. The injection port applier of claim 16, further comprising acam feature, wherein the cam feature is configured to rotate the secondportion of the shaft assembly in response to translation of the firstportion of the shaft assembly.
 18. The injection port applier of claim15, wherein the port actuator is rotatable to move the fasteners of theinjection port from the non-deployed position to the deployed position,wherein the shaft assembly is configured to rotate the port actuator inresponse to distal movement of the second handle portion.
 19. A methodof using an injection port applier to install an injection port in apatient, wherein the injection port has a plurality of fasteners,wherein the injection port is removably coupled with the injection portapplier, wherein the injection port applier comprises a fixed handle andan actuation handle, wherein the actuation handle is movable relative tothe fixed handle, wherein the actuation handle is operable to move thefasteners from a non-deployed position to a deployed position, themethod comprising: (a) positioning the injection port adjacent to tissueat a deployment site in a patient; and (b) pushing the actuation handledownwardly toward the patient in order to deploy the fasteners in thetissue, wherein the act of pushing the actuation handle downwardlycomprises moving the actuation handle downwardly relative to the fixedhandle.
 20. The method of claim 19, wherein the injection port applierfurther comprises a rotary actuator in communication with the actuationhandle, wherein the actuation handle is operable to rotate the rotaryactuator to move the fasteners from the non-deployed position to thedeployed position, wherein the act of pushing the actuation handledownwardly toward the patient further comprises rotating the rotaryactuator to move the fasteners from the non-deployed position to thedeployed position.